Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 17, 2019

Primary Completion Date

May 4, 2022

Study Completion Date

July 19, 2022

Conditions
Bloody DiarrheaSTEC, UnspecifiedHemolytic-Uremic SyndromePediatric Kidney Disease
Interventions
DRUG

INM004

"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."

DRUG

Placebo

"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."

Trial Locations (7)

1199

Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aire

1270

Hospital Elizalde, Buenos Aires

8000

Hospital Penna, Bahía Blanca

Unknown

Hospital Sor Maria Ludovica, La Plata

Hospital Lucio Molas, Santa Rosa

Hospital Castro Rendon, Neuquén

Hospital Orlando Alassia, Santa Fe

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Exeltis

INDUSTRY

lead

Inmunova S.A.

OTHER

NCT04132375 - Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS | Biotech Hunter | Biotech Hunter